Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial

Trial ID: NCT06050317

Interventional - Phase 2 - Recruiting

Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.

Conditions

ECOG PS 0-1
Pathological tissue-confirmed unresectable locally advanced pancreatic cancer
Pancreatic cancer patients who have not received systemic anti-tumor therapy
Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards
A life expectancy of \> 3 months
Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells/L, platelets ≥ 75×109 cells/L, hemoglobin ≥ 9.0 g/dl
AST\<2.5 × ULN(Upper Limit of Normal), ALT\<2.5 × ULN,creatinine ≤1.5xULN, total bilirubin \< ≤1.5 X ULN.

Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment
Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment
Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors
Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment
Abnormal results of blood routine examinations and liver and kidney and coagulation tests
Abnormal function of major organs (14 days before enrollment)
Women who are pregnant
Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Shandong Cancer Hospital and Institute